BI Nutraceuticals says it has validated a steam sterilization process for more than 350 botanicals. BI Nutraceuticals photo.

With 15 years of data, BI Nutraceuticals says its steam sterilization protocol is the most highly developed in the dietary supplement industry, and is part of what enables the company to fully comply with FSMA requirements.

BI first rolled out its process, which it calls Protexx HP Green Steam, in 2002. Since then the company says it has become the industry’s only species-specific, organic steam sterilization system with a validated kill step. Protexx HP utilizes more than 40 settings, which control heat, moisture, time, and pressure parameters, tailored for each individual species. BI says it has fine-tuned more than 350 product-specific, validated protocols across its five steam units that utilize the highest pressure and temperature settings in the industry, resulting in shorter treatment times to eliminate pathogens which help maintain the product’s characteristics. BI also has the only steam unit in the industry validated using the USP method, which is the most stringent test on the market for sterilization methods. BI’s USP method is tested and retested annually to ensure effectiveness.

Data specific to species improves process

But more than the species specificity, BI CEO George Pontiakos said a key difference is that the company has focused its process as far down the supply chain as possible.

“​We are the only sterilizers who sterilize plants in their whole form. When you sterilize powders, you can get all kinds of clumping and hot spots. It​’​s not efficient,​”​ Pontiakos told NutraIngredients-USA.

Pontiakos said that another differentiator is that BI has used purpose built machinery, which is part of how the process could be fine tuned for different species. For cost purposes, most other companies use existing machinery and try to retrofit it for their specific needs.

“​They are using sterilizers designed for nuts or for stems. They don​’​t work well for botanical products that can have high loads of pathogens,​”​ he said.

Pontiakos said the company’s long experience with the technology allows it to achieve the required level of pathogen reduction without compromising the sometimes delicate bioactive molecules within.

“​We have 15 years of data that tell us how to sterilize each biomass so that we clean it but we don​’​t kill the attributes that provide the efficacy in the first place,​”​ Pontiakos said.

Achieving FSMA compliance

Recently the Food and Drug Administration said that it would use enforcement discretion—essentially delaying full implementation—of several Food Safety Modernization Act rules. Feedback from industry led FDA to conclude that many companies would have difficulty complying with the provisions, in particular the requirement to get ‘written assurances’ from the supply chain about who is responsible for controlling for identified hazards.

Larisa Pavlick, head of regulatory and compliance for the United Natural Products Alliance, said getting these assurances has proven problematical​​, because many suppliers might be squeamish about putting in writing that they have been passing on material they know could be contaminated, even if their understanding has been that their customers take care of sterilization. In BI’s case, the company has been handling the pathogen hazard on its end in a highly publicized manner for years, so getting these assurances hasn’t been a big hurdle, Pontiakos said.

“We have already been managing the FSMA certification for our food and beverage clients. Everything that comes through our plant is not only GMP but also SQF compliant,​”​ Pontiakos said. “We​’ve had that for years.​”​

Need for testing

Sterilizing every lot of material is part of the company’s commitment to 100% testing throughout the manufacturing process, Pontiakos said. He said BI did not view favorably the recent support by the Natural Products Association for skip lot ID testing​​. While NPA’s position was that this applied to one company make one product in its facility, Pontiakos agreed with others that it could be a step off onto a slippery slope.

“​We don​’​t agree with skip lot testing. You have to decide for your own business how much risk you are willing to have. We have a ton of data that would support skip lot testing but we also have a ton of data that shows it could be dangerous,​”​ Pontiakos said.

“I think that in the landscape that we operate in there are still a number of suppliers out there that have zero ethics. There is certainly a supplier base out there that doesn​’t test, that doesn​’t have the capital base to afford to test. There are a lot of guys out there on the Internet side, using an Amazon model, who have no control over the product the customers are getting,​”​ he said.